We can provide complete suite of documentation and report templates OR can also work with our clients internal templates and processes. We also provide internal documentation improvement analysis, please view our Documentation Analysis Services.
- Engage with all levels of Business Team Stakeholders to develop a “Requirements Facilitation Team.”
- Identify Problems and Opportunity
- Provide Business Analysis Planning, Needs Assessment, and Solution Evaluation.
- Assess current state of the organization, projects and internal processes.
- Recommend Actions to Address Business Needs.
- Conduct and Refine Stakeholder Analysis
- Plan, Prepare, and Conduct Elicitation Activities
- Create Process Models, Rules Models, Data Models, Interface Models.
- Monitor Requirements via Traceability Matrix
- Evaluate Risk Impact Analysis
- Coordinate Test case development, User Acceptance Testing, and Quality Assurance Testing.
- Documentation Deliverables: User Requirement Specifications, Functional Requirement Specifications, Business Requirement Specifications, Data Integration Requirements Specification, UAT Test Scripts, Traceability Matrix, Risk Assessment Reports, and Solution Performance Reports.
Project Management
- Our Project Management services utilize high level of accountability when executing your projects.
- Initiate, Plan, Develop and Execute Process Groups.
- Develop Project Charter, Project Management Plan.
- Direct and Manage Project Execution.
- Provide end-to-end Project Scope Management.
- Manage Project Time Management.
- Manage Project Cost Management.
- Manage Project Procurement Processes.
- Manage Project Communications Plan.
- Manage Stakeholder Expectations .
- Initiate, Plan and Conduct Project Risk Analysis (Qualitative and Quantitative)
- Plan Risk Responses.
- Report Project Performance.
- Plan and Execute Project Quality Assurance Program.
Product Management
- Create Product Mission and Vision
- Conduct competitor product analysis
- Develop Product Roadmaps
- Develop Product Requirements Specification
- Mentor Product Development Team.
Computer System Validation Services
- Perform Part 11 Assessment
- Software Risk Assessment
- Perform IT Change Control for Regulated Systems i.e. GxP and SOX
- Documentation Deliverables : System Validation Plan, Test Protocol, Test Scripts, User Issue Log, Deviation Form, Trace Matrix, and Validation Summary Form
- Develop Data Integrity Program
- Develop Periodic Review Process
- Develop Regulatory Applicability Assessment
- Develop Computer Software Assurance initial validation and release management
- Develop ERES Compliance Assessment.
Documentation Analysis
- Development of Standard of Protocols
- Clinical and Technical Writing
- Template and Form Creation
- Development of Work Instruction Documentation
- Evaluate and Fix Incomplete Documentation (Scientific and Technical)
Technology Training
- Design Training Curriculum, User Guides and Learning Management System Modules.
- Conduct end-to-end technology training for technology products
- Develop Train-the-Trainer programs.
Pre-Sales Technology Solutioning
- Support in Creation of Request for Information questionnaire.
- Evaluation and scoring of of 3rd party Product Demonstrations.
- Perform Product Demo to your clients.
- Mentor internal team members on good technology presentation skills.
Reseller Partnerships
- We are open to becoming a reseller partner for your products and services.
- Build Network and Partnerships with other third-party vendors to support sales and marketing of qualified products and services.